UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
(State or other jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
||
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including
area code:
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
Securities registered pursuant to Section 12(b)-2 of the Exchange Act:
| Title of each class | Trading Symbol |
Name of each exchange on which registered | ||
Item 7.01 Regulation FD Disclosure.
On October 28, 2021, Rafael Holdings, Inc. (the “Registrant”) issued the attached release (the “Release”) providing an update on Rafael Pharmaceuticals’ AVENGER 500 Phase 3 Trial of CPI-613® (Devimistat) in Metastatic Pancreatic Cancer and Interim Analysis of ARMADA 2000 Phase 3 Trial in Relapsed or Refractory Acute Myeloid Leukemia. A copy of the Release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The Registrant is furnishing the information contained in this Report, including Exhibit 99.1, pursuant to Item 7.01 of Form 8-K promulgated by the Securities and Exchange Commission (the “SEC”). This information shall not be deemed to be “filed” with the SEC or incorporated by reference into any other filing with the SEC.
Item 8.01 Other Events.
The AVENGER 500 Phase 3 clinical trial for CPI-613® (devimistat), Rafael Pharmaceuticals’ lead product candidate, did not meet its primary endpoint of significant improvement in overall survival in patients with metastatic adenocarcinoma of the pancreas.
Following a pre-specified interim analysis, the independent data monitoring committee has recommended the ARMADA 2000 clinical trial of devimistat for patients with relapsed or refractory acute myeloid leukemia be stopped due to lack of efficacy.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit No |
Document | |
|
99.1 |
||
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RAFAEL HOLDINGS, INC. | |||
|
By: |
/s/ Ameet Mallik | ||
| Name: | Ameet Mallik | ||
| Title: | Chief Executive Officer | ||
Dated: October 28, 2021 |
|||
2
EXHIBIT INDEX
|
Exhibit |
Document | |
|
99.1 |
||
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
3